Time Delay Mechanism for a Hydraulic Drug Delivery Device

ABSTRACT

A medicament delivery device may comprise a medicament chamber configured to hold a medicament, a plunger configured to move relative to the medicament chamber to expel the medicament from the medicament chamber, a pin configured to move from a first pin position wherein the pin prevents movement of the plunger to a second pin position wherein the pin allows movement of the plunger, an actuation assembly configured to move the pin from the first pin position to the second pin position, and a needle coupled to the medicament chamber. The medicament may flow through the needle from the medicament chamber to a user. The actuation assembly may be configured to automatically move the pin after a predetermined time delay.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims the benefit of U.S. Provisional PatentApplication No. 62/522,649 filed Jun. 20, 2017 entitled “Time DelayMechanism for a Hydraulic Drug Delivery Device”, which is incorporatedby reference herein in its entirety.

BACKGROUND OF THE INVENTION

The present invention generally relates to a drug delivery device and,more particularly, to a time delay mechanism for a drug delivery device.

BRIEF SUMMARY OF THE INVENTION

In one embodiment there is a medicament delivery device that maycomprise a medicament chamber configured to hold a medicament, a plungerconfigured to move relative to the medicament chamber to expel themedicament from the medicament chamber, a pin configured to move from afirst pin position wherein the pin prevents movement of the plunger to asecond pin position wherein the pin allows movement of the plunger, anactuation assembly configured to move the pin from the first pinposition to the second pin position, and a needle coupled to themedicament chamber. The medicament may flow through the needle from themedicament chamber to a user. The actuation assembly may be configuredto automatically move the pin after a predetermined time delay.

The actuation assembly may comprise an adapter coupled to the pin and anactivator configured to move the adapter from a first adapter positionto a second adapter position, thereby moving the pin from the first pinposition to the second pin position. The adapter may include an internalopening configured to receive at least a portion of the pin. The adaptermay include a deflectable flange configured to engage a rim of the pin.

In a further embodiment, the actuation assembly may comprise a gearhaving an internal opening configured to receive the adapter. Theadapter may be configured to move relative to the gear. The internalopening of the gear may be defined by a threaded perimeter wall and theadapter may comprise an external thread configured to mate with thethreaded perimeter wall. The activator may be configured to rotate thegear and the adapter may be configured to move relative to the gear asthe gear rotates. The activator may comprise a motor.

In a further embodiment, the medicament delivery device may include adrive gear coupled to the motor, the drive gear configured to mesh withthe gear such that the motor rotates the gear as the motor rotates thedrive gear. The medicament delivery device may further include a housingconfigured to receive at least a portion of the medicament chamber, theplunger, and the pin. The actuation assembly may be detachably coupledto the housing. The adapter may be rotationally fixed relative to thehousing.

The actuation assembly may further include an engagement member coupledto the adapter, the engagement member configured to move relative to theadapter from a first engagement member position to a second engagementmember position; and a catch configured to prevent movement of theengagement member when the engagement member is in the first engagementposition. The adapter may be moveable from the first adapter position tothe second adapter position when the engagement member may be in thesecond engagement member position. The activator may include a biasingelement configured to urge the engagement member toward the secondengagement member position.

In a further embodiment, the delivery device may include an actuatorconfigured to move the engagement member from the first engagementmember position to the second engagement member position.

In one embodiment there is a medicament delivery device that maycomprise a first chamber including a first plunger, the first plungerconfigured to move relative to the first chamber and a second chamberfluidly connected to the first chamber. The second chamber may beconfigured to receive fluid from the first chamber when the firstplunger moves relative to the first chamber. The medicament deliverydevice may include a third chamber including a third plunger, the thirdchamber fluidly connected to the first chamber. The third chamber may beconfigured to contain a medicament and the third plunger may beconfigured to move relative to the third chamber when the first plungermoves relative to the first chamber. The medicament delivery device mayinclude a biasing element configured to move the first plunger relativeto the first chamber and a needle coupled to the third chamber. Theneedle may be configured to provide a pathway for the medicament to flowfrom the third chamber to a user as the third plunger moves relative tothe third chamber.

The first chamber may be configured to receive a fluid, wherein at leasta portion of the fluid may be transferred from the first chamber to thesecond chamber as the first plunger moves relative to the first chamber.The second chamber may include a second plunger configured to moverelative to the second chamber as the fluid is transferred from thefirst chamber to the second chamber. The second chamber may include aflexible membrane configured to move relative to the second chamber asthe fluid is transferred from the first chamber to the second chamber.The second chamber may include an expandable membrane configured toexpand relative to the second chamber as the fluid is transferred fromthe first chamber to the second chamber. The second chamber may includea gas permeable membrane configured to allow gas to escape from thesecond chamber but prevent fluid from exiting the second chamber as thefluid is transferred from the first chamber to the second chamber. Atleast a portion of the fluid may be transferred from the first chamberto the third chamber as the first plunger moves relative to the firstchamber. The medicament delivery device may be configured to transferthe fluid from the first chamber to the second chamber before the fluidis transferred from the first chamber to the third chamber.

The medicament delivery device may be configured such that there may bea time delay between a time when first piston begins to move relative tothe first chamber and the third piston begins to move relative to thethird chamber. The first chamber may include a bypass, wherein the fluidflows through the bypass before transferring from the first chamber tothe third chamber. The first plunger may include a first collar having afirst collar diameter and a body having a body diameter, wherein thebody diameter is less than the first collar diameter. The first plungermay include a second collar having a second collar diameter, wherein thebody diameter is less than the second collar diameter. The second collardiameter may be substantially the same as the first collar diameter. Thefirst chamber may include a distal portion between a distal end of thefirst chamber and the first collar, and the first chamber may include aproximal portion between the first collar and the second collar. Fluidmay flow from the distal portion through the bypass and into theproximal portion as the first plunger moves relative to the firstchamber. Fluid may be transferred from the proximal portion of the firstchamber into the third chamber.

The second chamber may be fluidly connected to the first chamber by afirst passage having a first passage diameter, the third chamber may befluidly connected to the first chamber by a second passage having asecond passage diameter, and the first passage diameter may be smallerthan the second passage diameter. The first passage may include a firstpassage length, the second passage may include a second passage length,and the first passage length may be greater than the second passagelength. The first passage length may be greater than the second passagelength by an amount equal to or greater than a third chamber diameter. Avolumetric flow rate of the fluid from the first chamber to the secondchamber may be smaller than a volumetric flow rate of the fluid from thefirst chamber to the third chamber. Transfer of fluid into the thirdchamber may move the third plunger relative to the third chamber therebyexpelling the medicament from the third chamber through the needle andto the user.

The medicament delivery device may include a pin configured to move froma first pin position wherein the pin prevents movement of the firstplunger to a second pin position wherein the pin allows movement of thefirst plunger relative to the first chamber. The actuation assembly maybe configured to move the pin from the first pin position to the secondpin position.

BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS

The following detailed description of the time delay mechanism for adrug delivery device will be better understood when read in conjunctionwith the appended drawings of exemplary embodiments. It should beunderstood, however, that the invention is not limited to the precisearrangements and instrumentalities shown.

In the drawings:

FIG. 1 is a trimetric view of a delivery device in accordance with anexemplary embodiment of the present invention;

FIG. 2 is a top cross sectional view of the delivery device shown inFIG. 1 taken along a plane, the location and direction being indicatedby line 2-2;

FIG. 3 is a front cross sectional view of the delivery device shown inFIG. 1 taken along a plane, the location and direction being indicatedby line 3-3;

FIG. 4 is a side trimetric view of the delivery device of FIG. 1 with anactuation assembly in accordance with an exemplary embodiment of thepresent invention attached thereto;

FIG. 5 is a bottom trimetric view of the actuation assembly of FIG. 4;

FIG. 6 is a sectional trimetric view of an interface adapter componentof FIG. 4;

FIG. 7 is a top, side, sectional trimetric view of the actuationassembly of FIG. 4;

FIG. 8 is a top, side, sectional trimetric view of the delivery deviceand actuation assembly of FIG. 4;

FIG. 9 is a top, side, sectional trimetric view of the delivery deviceand actuation assembly of FIG. 4;

FIG. 10 is a side trimetric view of the delivery device of FIG. 1 withan actuation assembly in accordance with another exemplary embodiment ofthe present invention attached thereto;

FIG. 11 is a side trimetric view of the delivery device and actuationassembly of FIG. 10;

FIG. 12 is a side trimetric view of the delivery device and actuationassembly of FIG. 10;

FIG. 13 is a top, side trimetric view of a delivery device in accordancewith another embodiment of the present invention;

FIG. 14 is a top, side trimetric view of the delivery device of FIG. 13;and

FIG. 15 is a top, side trimetric view of the delivery device of FIG. 13.

DETAILED DESCRIPTION OF THE INVENTION

Referring to the drawings in detail, wherein like reference numeralsindicate like elements throughout, there is shown in FIGS. 1-15 adelivery device, generally designated 20, in accordance with anexemplary embodiment of the present invention. The delivery device 20may be coupled to a user's skin to deliver a substance to a user such asa drug or medicament. The delivery device 20 may be configured todeliver medicament to a user after a time delay as explained in greaterdetail below. The delivery device 20 may be configured to deliver amedicament subcutaneously to a user after a delay of a selected orpredetermined time period. The delivery device 20 may include a patch 22which couples the delivery device 20 to a user's skin. The patch 22 maybe an adhesive patch that self-adheres to the user's skin. The deliverydevice 20 may include a housing 24 coupled to the patch 22.

In one embodiment, the delivery device 20 is a discrete ambulatoryinsulin delivery pump. Delivery device 20 may be single use, disposableand incapable of reuse. The delivery device 20 may provide therapeuticcapability in a small, single use, disposable package and at least someportions can be produced using high volume manufacturing fabrication(e.g., injection molding) and assembly processes, allowing for low costof goods. Embodiments of the delivery device 20 can be used for a broadrange of applications, including, but not limited to, clinicalapplications (e.g., administration of medicaments, etc.) and biomedicalresearch (e.g., microinjection into cells, nuclear or organelletransplantation, isolation of single cells or hybridomas, etc.).

In one embodiment, delivery device 20 is a device for dispensing,delivering, or administering fluid or agent to the user or patient. Thefluid may be a low viscosity gel agent and or a therapeutic agent. Inone embodiment, the delivery device 20 is configured to deliverNeulasta® (pegfilgrastim) to a user to stimulate the production of whiteblood cells in chemotherapy patients. Other drugs that require delayedtiming include chemotherapy agents, hypertension treatments deliveredwhile sleeping, anti-depressives and pain medication. In one embodiment,the fluid is an analgesic agent. In one embodiment, the fluid is insulinof any type. In other embodiments, the fluid may be, but is not limitedto, opiates and/or other palliatives or analgesics, hormones,psychotropic therapeutic compositions, or any other drug or chemicalwhose continuous dosing, with or without a time delay, is desirable orefficacious for use in treating patients. Single fluids and combinationsof two or more fluids (admixed or co-administered) may be deliveredusing delivery device 20. As used herein “patients” or “user” can behuman or non-human animals; the use of delivery device 20 is notconfined solely to human medicine, but can be equally applied toveterinarian medicine.

The delivery device 20 may dispense the fluid over a sustained period oftime (i.e., basal delivery). In one embodiment, the fluid delivery rateis continuously or near continuously delivered to the user over thesustained period of time. As explained in greater detail below, thedelivery device 20 may dispense the fluid over a sustained period oftime but the delivery may not begin until after a selected orpredetermined time delay. A time delay may allow a caregiver toadminister an initial dose of medicament to a patient and attach thedelivery device 20 such that a second dose of medicament is delivered tothe patient on a selected schedule.

Referring to FIG. 2, the delivery device 20 may include a medicamentchamber 26 within the housing 24. A plunger 28 may be positioned in themedicament chamber 26. The plunger 28 may be moveable within themedicament chamber 26 to expel medicament from the medicament chamber 26as explained in greater detail below. In one embodiment, the plunger 28is moved relative to the medicament chamber 26 by fluid pressure (e.g.,hydraulic fluid). In another embodiment, the plunger 28 is moveddirectly or indirectly by a biasing element (e.g., a spring) or gaspressure.

The delivery device 20 may include a second chamber 30 containing fluid.A second plunger 32 may be positioned in the second chamber 30. Thesecond chamber 30 may be fluidly connected to the medicament chamber 26by a channel. The second plunger 32 may be moveable relative to thesecond chamber 30 to expel the fluid from the second chamber 30 throughthe channel and into the medicament chamber 26. A wall 34 may bepositioned at a proximal end 36 of the second chamber 30. The wall 34may be fixed relative to the second chamber 30. A biasing element 38 maybe positioned between the fixed wall 34 and a portion of the plunger 32.The biasing element 38 (e.g., a spring or compressed gas) may move froma compressed state to a decompressed state thereby moving the plunger 32toward a distal end 40 of the second chamber.

A catch such as a pin 42 may be coupled to the second plunger 32 toprevent the second plunger from moving relative to the second chamber30. In one embodiment, the pin 42 has a circular cross section. In oneembodiment, the pin 42 has a non-circular cross section such as square.The pin 42 may extend through, or be coupled to, the housing 24 suchthat the pin 42 contacts the housing thereby preventing movement of thesecond plunger 32 when the pin is in a first pin position. The pin 42may be movable relative to the second plunger 32. The pin 42 may bemoveable from the first pin position where the pin 42 prevents movementof the second plunger 32 to a second pin position where the pin 42allows movement of the second plunger 32. Decoupling the pin 42 from thesecond plunger 32 may allow the second plunger to move relative to thesecond chamber 30. The pin 42 could also, or alternatively, be coupledto the plunger 28 of the medicament chamber 26. In one embodiment, thesecond plunger 32 may include a recess or hole to receive the pin 42. Inanother embodiment, the second plunger 32 may include a shoulder orprotrusion to engage the pin 42 such that the second plunger 32 isrestrained from moving toward the distal end of the second chamber 30when the pin 42 is in the first pin position.

The biasing element 38 may move the second plunger 32 toward the distalend 40 of the second chamber 30 when the pin 42 is decoupled from thesecond plunger 32. The movement of the second plunger 32 relative to thesecond chamber 30 may expel the fluid from the second chamber 30 throughthe channel and into the medicament chamber 26. Thus, the biasingelement 38 may cause each of the second plunger 32 and the plunger 28 tomove relative to the second chamber 30 and the medicament chamber 26,respectively. The plunger 28 may separate the medicament from the fluidin the medicament chamber 26 such that as the fluid from the secondchamber 30 enters the medicament chamber 26, the medicament is expelledthrough a needle 44 and into the user (needle 44 best seen in FIG. 3).

The delivery device 20 may include a communication module configured tocommunicate with a remote device. The communication module may beconfigured to communicate via a wired connection or wirelessly (e.g.,near field communication (NFC), infrared (IR) wireless communication,Bluetooth, or Zigbee). The communication module may communicate with anapplication on a user's phone or computer. The app may cause the user'sphone to provide a signal (e.g. audible or tactile notification) tonotify a user when to begin delivery of the medicament from the deliverydevice 20. The communication module may be coupled to the pin 42 suchthat removing the communication module when alerted to do so begins thedelivery of the medicament. The communication module may transmit asignal to the app that the module was removed at the proper time. A usermay input a signal into the app that the delivery device 20 has beencoupled to the user and the app may send a second signal after aselected time delay to notify the user to activate the delivery device20 by removing the pin 42.

The delivery device 20 may include a timer configured to notify a userwhen to begin the delivery of the medicament and/or when to remove thedelivery device 20. The timer may include an alarm to provide an audio,visual, and/or tactile signal to a user to activate the delivery device20 to deliver the medicament. The timer may be connected to the pin 42such that removing the timer from the delivery device 20 activates thedelivery device. In one embodiment, the timer is an external device thatis attached to the delivery device. In one embodiment, the timer ispositioned within the housing 24.

Referring to FIG. 4, an actuation assembly 46 may be coupled to thedelivery device 20. Some of the elements are removed from the deliverydevice 20 as shown in FIG. 4 for ease of discussion. The actuationassembly 46 may be configured to activate the delivery device 20 after aselected time delay. The actuation assembly 46 may be coupled to anexisting delivery device 20. In one embodiment, the user of the deliverydevice 20 connects the actuation assembly 46 with the delivery device20. In one embodiment, the actuation assembly 46 is coupled to thedelivery device 20 during manufacturing so that the user receives thedelivery device 20 with actuation assembly 46 already coupled to thedelivery device 20. In one embodiment, the actuation assembly 46 isintegrally formed with the delivery device 20. In one embodiment, theactuation assembly 46 is removably coupled to the delivery device 20. Inone embodiment, the actuation assembly 46 locks onto the delivery device20 and is not intended to be removed from the delivery device 20.

The actuation assembly 46 may be configured to move the pin 42 from thefirst pin position (FIG. 8) to the second pin position (FIG. 9) asexplained in greater detail below. The actuation assembly 46 may beconfigured to delay the start of delivery 20. For example, the deliverydevice 20 may be attached to the user and the user or the caregiver maystart the actuation assembly 46 so that the delivery device 20 is notactivated until after a predetermined time delay as set by the actuationassembly 46. The time delay may be any desired amount of time. The timedelay may be about 1 second, about 5 seconds, about 10 seconds, about 30seconds, about 1 minute, about 5 minutes, about 15 minutes, about 30minutes, about 45 minutes, about 1 hour, about 3 hours, about 5 hours,about 10 hours, about 15 hours, about 18.5 hours, about 20 hours, about24 hours, about 36 hours, or about 48 hours.

Referring to FIGS. 4-7, the actuation assembly 46 may include an adapter48 (FIG. 7) configured to engage the pin 42 (see FIG. 2). The adapter 48may include an internal opening 50 configured to receive at least aportion of the pin 42. One or more flanges 52 may extend into theinternal opening 50. The flanges 52 may engage the pin 42 when the pin42 is in the internal opening 50. The pin 42 may include a head 54 and abody 57. A neck 59 may be formed between the head 54 and the body 57 ofthe pin 42. The neck 59 may have a smaller diameter than the head 54and/or the body 57 such that the flanges 52 engage the neck 59 when thehead 54 is within the internal opening 50. The flanges 52 may beresilient such that the flanges deflect as the head 54 enters theinternal opening 50 and contacts the flanges 52. The flanges 52 mayreturn to their undeflected state when the flanges 52 are adjacent theneck 59. In some embodiments, the adapter 48 includes a magnet and thepin 42 comprises a magnetic or ferrous material such that the adapter 48is magnetically coupled to the pin 42.

Referring to FIG. 5, the actuation assembly 46 may include a gear 56.The gear 56 may be configured to rotate relative to the actuationassembly 46. The actuation assembly may include an activator 58configured to rotate the gear 56. In one embodiment, the activator 58 isa DC motor such as Precision Microdrives model 103-100 or model 124-002.In another embodiment, the activator 58 is a pull string, a turnableknob, or a crank handle. In one embodiment, the activator 58 is coupledto a drive gear 60 which meshes with the gear 56 such that the activator58 rotates the drive gear 60 which causes the gear 56 to rotate. Inanother embodiment, the activator 58 is coupled to the gear 56 such thatthe motor rotates gear 56.

Referring to FIGS. 5-7, the gear 56 may include an internal opening 62configured to receive the adapter 48. The adapter 48 may move relativeto the gear 56 as the gear rotates. The internal opening 62 may bedefined by a threaded perimeter wall 64. The adapter 48 may include anexternal thread 66 configured to mesh with the threaded perimeter wall64 such that relative rotation between the gear 56 and the adapter 48causes translation of the adapter 48 relative to the gear 56. Theactuation assembly 46 may include one or more posts 68. The posts 68 maybe fixed to an actuation assembly housing 70. The adapter 48 may includeopenings to slidingly receive the posts 68 such that the adapter 48 cantranslate relative to the posts 68 and the gear 56. The posts 68 mayrotatingly fix the adapter 48 relative to the actuation assembly 46and/or the gear 56 as the gear 56 rotates such that the threadedengagement between the adapter 48 and the gear 56 causes the adapter 48to translate as the gear rotates.

Referring to FIGS. 4-5, the actuation assembly housing 70 may include atop wall 72 with sidewalls 74 extending away from the top wall 72. Arear wall 76 may be coupled to the sidewalls 74. A relief 78 may beformed at the transition between the sidewall 74 and the rear wall 76such that the sidewall 74 can flex independently from the rear wall 76as the housing 70 is positioned on the delivery device 20. The sidewalls74 may include a first portion 80 adjacent the rear wall 76 and a secondportion 82 adjacent the first portion 80. The first portion 80 mayextend away from the top wall 72 further than the second portion 82. Thelength of the first portion 80 and the rear wall 76 may help align theactuation assembly 46 on the delivery device 20 as the actuationassembly 46 is coupled to the delivery device 20. Aligning the actuationassembly 46 on the delivery device 20 may ensure that the adapter 48receives a portion of the pin 42 when the actuation assembly 46 iscoupled to the delivery device 20. The sidewalls 74 may include features71 (FIG. 4) to secure the housing 70 to the delivery device 20. Thefeatures 71 may engage housing features 73 (best seen in FIG. 11). Inone embodiment, the sidewall features 71 may be a protrusion and thehousing feature 73 may be a recess configured to at least temporarilyreceive the protrusion. In another embodiment, the sidewall feature 71is a recess and the housing feature 73 is a protrusion. In anotherembodiment, feature 71 and feature 73 are both holes configured toreceive a dowel, pin, screw, or fastener. In yet another embodiment,feature 71 and feature 73 form a hook and loop fastener (e.g., Velcro)or are magnets. Projections (not shown) may be formed at the bottomedges of the sidewalls 80 to make it easier to grip the housing forremoval. The top wall 72 may include a window 84. The window 84 mayallow a user to observe a dosage indicator 86 in the delivery device 20(FIG. 1) or the contents of the delivery device medicament chamber 26.

Referring to FIGS. 8-9, the adapter 48 may move from the first adapterposition (FIG. 8) to the second adapter position (FIG. 9) as the gear 56rotates. The flanges 52 may contact the head 54 of the pin 42 and movethe pin 42 from the first pin position to the second pin position as theadapter 48 is moved from the first pin position to the second pinposition. The biasing element 38 (FIG. 2) may move the second plunger 32after the pin 42 is moved to the second pin position. Fluid may betransferred from the second chamber 30 to the medicament chamber 26 asthe second plunger 32 is moved by the biasing element 38 thereby movingthe plunger 28 to move. The medicament may be dispensed from themedicament chamber 26 plunger 28 moves. In some embodiments, the secondplunger 32 does not move until the adapter 48 or activator 58 hasstopped moving. In some embodiments, the delivery device includesdiscrete steps of movement of the activator 58 and then movement of thesecond plunger 28.

Referring to FIGS. 10-12, there is shown a second embodiment of theactuation assembly, generally designated 88. The actuation assembly 88may be similar to the first embodiment of the actuation assembly 46, butone difference is that the actuation assembly 88 does not include a gear56.

The actuation assembly 88 may include an engagement member 90 coupled toan adapter 92. The adapter 92 may include the internal opening 50 andflanges 52 to engage the pin 42 as previously described. The engagementmember 90 may be moveable relative to the adapter 92 from a firstengagement member position (FIG. 11) to a second engagement memberposition (FIG. 12). In one embodiment, the engagement member 90 isslidably coupled to the adapter 92 such that the engagement member 90 isslidable along a first axis 100 relative to the adapter 92. Theengagement member 90 may include an opening 94 to receive the pin head54 when the pin 42 is engaged by the adapter 92.

The engagement member 90 may be moveable along a second axis 102relative to the actuation assembly 88 (FIGS. 11-12). The engagementmember may include an aperture 96 configured to receive a post 98. Thepost 98 may include a catch 104 (FIG. 12) configured to prevent movementof the engagement member 92 along the second axis 102. The catch 104 maybe a notch or a portion of the post 98 having a reduced thicknesscompared to an adjacent portion of the post 98. The post 98 may includea shoulder at the catch 104 such that the catch 104 engages a surface oredge of the engagement member 94 to prevent the engagement member frommoving along the second axis 102 when the engagement member is in thefirst engagement member position. In one embodiment, the second axis 102is orthogonal to the first axis 100. In another embodiment, the secondaxis 102 is oblique to the first axis 100.

The engagement member 90 may be moveable along the first axis 100 fromthe first engagement member position where the catch 104 preventsmovement of the engagement member 90 along the second axis 102 to thesecond engagement member position where the engagement member can movealong the second axis 102. In one embodiment, the catch 104 extendsaround the perimeter of the post 98. In another embodiment, the catch104 is formed on only a portion of the perimeter of the post 98 toprevent accidental engagement between the catch 104 and the engagementmember 90 when the engagement member is moved to the second position. Instill another embodiment, one side of the sidewall of the aperture 96 isthicker than another side such that the catch 104 can only engage theengagement member 90 when the engagement member is in the firstengagement member position.

Referring to FIGS. 11-12, the actuation assembly 88 may include abiasing element 106 configured to urge the adapter 92 toward the secondadapter position. In one embodiment, the biasing element 106 is aspring. The actuation assembly 88 may include a base plate 108 and thebiasing element 106 may be coupled to the base plate 108 and the adapter92. The biasing element 106 may move the adapter 92 to the secondadapter position (FIG. 12) when the engagement member 90 disengages fromthe catch 104. The adapter 92 may move the pin 42 from the first pinposition to the second pin position as the adapter 92 moves from thefirst adapter position (FIG. 11) to the second adapter position (FIG.12). The actuation assembly 88 may include an actuator (not shown)configured to move the engagement member from the first engagementmember position to the second engagement member position. In oneembodiment, the actuator could be the gear 56 and activator 58 such thatrotation of the gear 56 causes the engagement member 90 to move alongthe first axis 100. In another embodiment, a user may manually move theengagement member either by manually engaging the engagement member orengaging an element coupled to the engagement member.

Rather than have an external device control the activation of thedelivery device 20, the delay mechanism may be internal to the housing24. For example, referring to FIGS. 13-15, there is shown a secondembodiment of a delivery device, generally designated 110. The deliverydevice 110 is similar to the delivery device 20 previously described andsome of the features have been omitted in FIGS. 13-15 for ease ofdiscussion. The delivery device 110 may be configured to delivermedicament to a user upon activation of the delivery device 110 andafter a pre-determined time delay. One or more features of the deliverydevice 110 may be selected to provide a desired time delay, as explainedin greater detail below.

The delivery device 110 may include a first chamber 112 with a firstplunger 114 in the first chamber 112. The first plunger 114 may bemoveable relative to the first chamber 112. The first chamber mayinclude a biasing element 116 configured to urge the first plunger 114toward a distal end 118 of the first chamber 112. The first plunger 114may be at least temporarily held in place by the pin 42 as previouslydescribed and the pin may be moved by one of the actuation assemblies46, 88 as previously described. The first chamber 112 may be configuredto receive a fluid (e.g., hydraulic fluid).

The delivery device 110 may include a second chamber 120. The secondchamber may be sealed with a membrane. The membrane (not shown) could bea flexible membrane, an expandable membrane, or a gas permeablemembrane. The delivery device 110 may include a second plunger 122 inthe second chamber 120. The second plunger 122 may fluidly seal thesecond chamber 120. The membrane or second plunger 122 may be configuredto move relative to the second chamber 120 when the first plunger 114moves relative to the first chamber 112. The second chamber 120 may beconfigured to receive the fluid from the first chamber. A first passage124 may fluidly connect the first chamber 112 to the second chamber 120.Fluid may be transferred from the first chamber 112 through the firstpassage 124 and into the second chamber 120 as the first piston 114moves relative to the first chamber 112. The second piston 122 may moverelative to the second chamber 120 as the fluid enters the secondchamber 120. In another embodiment, the second chamber 120 is sealedwith a gas permeable membrane that allows air to escape as the fluid istransferred from the first chamber 112 but prevents the fluid fromescaping.

The delivery device 110 may include a third chamber 126. A third plunger128 may be movably positioned in the third chamber 126. The thirdchamber 126 may be adapted to receive medicament. The medicament fromthe third chamber 126 may be delivered through a needle to a user whenthe third plunger 128 moves relative to the third chamber 126 aspreviously described. The third chamber 126 may include an end cap 127configured to be fluidly coupled to the needle 44 and the third chamber126 such that the medicament is transferred from the third chamber 126through the needle and to a user. The third chamber 126 may beconfigured to expel medicament from the third chamber 126 when the firstplunger 114 moves relative to the first chamber 112. The third plunger128 may fluidly seal the third chamber 126 such that the medicament inthe third chamber 126 is separated from the fluid entering the thirdchamber 126.

A second passage 130 may fluidly connect the first chamber 112 to thethird chamber 126. At least a portion of the fluid from the firstchamber 112 may flow into the third chamber 126 as the first plunger 114moves relative to the first chamber 112. In one embodiment, the fluidflows from the first chamber 112 into the second chamber 120 before thefluid flows from the first chamber 112 into the third chamber 126. Inone embodiment, a diameter of the first passage 124 is smaller than adiameter of the second passage 130. The length of the first passage 124may be greater than the length of the second passage 130. The length ofthe first passage 124 may exceed the length of the second passage 130 bya length equal to or greater than a diameter of the third chamber 126.

The first plunger 114 may include a first collar 132 configured tofluidly seal the first chamber 112. The first collar 132 may have anouter diameter substantially similar to, or slightly larger than, thediameter of the first chamber 112 such that fluid is prevented fromflowing past the first collar 132. The first plunger 114 may include abody 134 adjacent the first collar 132. The body 134 may have a diametersmaller than the first collar 132 and the first chamber 112 such thatfluid can flow around the body 134. The first plunger 114 may include asecond collar 136 having a diameter substantially similar to or the sameas the first collar 132.

The first chamber 112 may include a distal portion 140 between thedistal end 118 of the first chamber 112 and the first collar 132. Aproximal portion 142 of the first chamber 112 may be between the firstcollar 132 and the second collar 136 of the first plunger 114. The firstchamber 112 may include a bypass 138. The bypass 138 may be a recess ina sidewall of the first chamber 112 such that fluid can flow from thedistal portion 140 through the bypass 138 and into the proximal portion142. The fluid may flow from the proximal portion 142 through the secondpassage 130 and into the third chamber 126. However, in someembodiments, the bypass 138 does not extend the entire length of thefirst chamber 112 such that the fluid does not flow from the distalportion 140 to the proximal portion 142 until the first collar 132 ismoved adjacent the bypass 138. Thus, the fluid may flow into the secondchamber 120 before fluid flows into the third chamber 126. The fluid mayflow into the second chamber 120 and the third chamber 126simultaneously once the fluid has begun flowing into the third chamber126. The time necessary for the first plunger 114 to move such that thefirst collar 132 is adjacent the bypass 138 may be the selected timedelay. The spring constant of the biasing element 116, the frictionbetween the first plunger 114 and the first chamber 112, and the lengthof the first chamber 112 may be selected to achieve the selected timedelay.

The length, diameter, and/or material of the first passage 124 and thesecond passage 130 and the viscosity of the hydraulic fluid in the firstchamber 112 may be selected to vary the volumetric flow rate througheach of the first passage 124 and the second passage 130. The flow ratethrough the first passage 124 may be slower than the flow rate throughthe second passage 130. The flow rate through the first passage 124 mayat least partially influence the movement rate of the first piston 114relative to the first chamber 112. For example, a shorter first passage124 may provide a greater flow rate of the fluid through the firstpassage than a longer first passage 124. A relatively larger diameterfirst passage 124 may allow a greater flow rate of the fluid through thefirst passage than a relatively smaller diameter first passage 124. Theflow rate through the first passage 124 may influence a time delay froma time the first plunger 114 begins to move relative to the firstchamber 112 until the fluid flows into the third chamber 126. Thus, thediameter and/or the length of the first passage may be selected suchthat a desired time delay is achieved. In one embodiment, the time delayis measured from the time the pin 42 is removed until medicament isdispensed from the third chamber 126.

The delivery time may be the time from when the third plunger 128 beginsto move relative to the third chamber 126 until a dose of medicament isdelivered to the user. The third plunger 128 may not need to travel thefull distance of the third chamber 126 for a dose of medicament to bedelivered. The movement of the third plunger 128 relative to the thirdchamber 126 may be faster than the movement of the second plunger 122relative to the second chamber 120. In one embodiment, the time delay islonger then the delivery time. In another embodiment, the time delay isequal to the delivery time. In yet another embodiment, the time delay isless than the delivery time.

It will be appreciated by those skilled in the art that changes could bemade to the exemplary embodiments shown and described above withoutdeparting from the broad inventive concepts thereof. It is understood,therefore, that this invention is not limited to the exemplaryembodiments shown and described, but it is intended to covermodifications within the spirit and scope of the present invention asdefined by the claims. For example, specific features of the exemplaryembodiments may or may not be part of the claimed invention and variousfeatures of the disclosed embodiments may be combined. The words“right”, “left”, “lower” and “upper” designate directions in thedrawings to which reference is made. The words “inwardly” and“outwardly” refer to directions toward and away from, respectively, thegeometric center of the drug delivery device. Unless specifically setforth herein, the terms “a”, “an” and “the” are not limited to oneelement but instead should be read as meaning “at least one”.

It is to be understood that at least some of the figures anddescriptions of the invention have been simplified to focus on elementsthat are relevant for a clear understanding of the invention, whileeliminating, for purposes of clarity, other elements that those ofordinary skill in the art will appreciate may also comprise a portion ofthe invention. However, because such elements are well known in the art,and because they do not necessarily facilitate a better understanding ofthe invention, a description of such elements is not provided herein.

Further, to the extent that the methods of the present invention do notrely on the particular order of steps set forth herein, the particularorder of the steps should not be construed as limitation on the claims.Any claims directed to the methods of the present invention should notbe limited to the performance of their steps in the order written, andone skilled in the art can readily appreciate that the steps may bevaried and still remain within the spirit and scope of the presentinvention.

1. A medicament delivery device comprising: a medicament chamberconfigured to hold a medicament; a plunger configured to move relativeto the medicament chamber to expel the medicament from the medicamentchamber; a pin configured to move from a first pin position wherein thepin prevents movement of the plunger to a second pin position whereinthe pin allows movement of the plunger; an actuation assembly configuredto move the pin from the first pin position to the second pin position;and a needle coupled to the medicament chamber, wherein the medicamentflows through the needle from the medicament chamber to a user; ahousing configured to receive at least a portion of the medicamentchamber, the plunger, and the pin, wherein the actuation assembly isdetachably coupled to the housing, and wherein the actuation assemblycomprises: an adapter coupled to the pin; and an activator configured tomove the adapter from a first adapter position to a second adapterposition, thereby moving the pin from the first pin position to thesecond pin position.
 2. (canceled)
 3. The medicament delivery device ofclaim 1, wherein the adapter includes an internal opening configured toreceive at least a portion of the pin.
 4. The medicament delivery deviceof claim 3, wherein the adapter includes a deflectable flange configuredto engage a rim of the pin.
 5. The medicament delivery device of claim1, wherein the actuation assembly further comprises: a gear having aninternal opening configured to receive the adapter, wherein the adapteris configured to move relative to the gear.
 6. The medicament deliverydevice of claim 5, further comprising: a drive gear coupled to theactivator, the drive gear configured to mesh with the gear such that theactivator rotates the gear as the activator rotates the drive gear. 7.The medicament delivery device of claim 1, wherein the actuationassembly further comprises: an engagement member coupled to the adapter,the engagement member configured to move relative to the adapter from afirst engagement member position to a second engagement member position;and a catch configured to prevent movement of the engagement member whenthe engagement member is in the first engagement member position,wherein the adapter is moveable from the first adapter position to thesecond adapter position when the engagement member is in the secondengagement member position.
 8. The medicament delivery device of claim7, wherein the activator comprises a biasing element configured to urgethe engagement member toward the second engagement member position. 9.The medicament delivery device of claim 7, further comprising: anactuator configured to move the engagement member from the firstengagement member position to the second engagement member position. 10.The medicament delivery device of claim 1, wherein the actuationassembly is configured to automatically move the pin upon activationafter a predetermined time delay. 11-23. (canceled)
 24. The medicamentdelivery device of claim 1, further comprising an adhesive patch forcoupling the medicament delivery device to a user's skin, wherein thehousing is coupled to the adhesive patch.
 25. The medicament deliverydevice of claim 1, wherein the medicament delivery device is configuredto be single-use.
 26. The medicament delivery device of claim 1, whereinthe medicament comprises insulin.
 27. The medicament delivery device ofclaim 1, wherein the medicament delivery device is configured todispense the medicament over a sustained period of time for providing abasal delivery of the medicament.
 28. The medicament delivery device ofclaim 1, further comprising a biasing element, wherein the plunger isconfigured to move directly or indirectly by the biasing element.
 29. Amethod of operating a medicament delivery device comprising: anactuation assembly; a housing; a medicament chamber configured to hold amedicament; and a plunger configured to move relative to the medicamentchamber to expel the medicament from the medicament chamber; and a pinconfigured to move from a first pin position wherein the pin preventsmovement of the plunger to a second pin position wherein the pin allowsmovement of the plunger; wherein the method comprises: detaching theactuation assembly from the housing of the medicament delivery device,such to move the pin from the first pin position to the second pinposition.
 30. The method of claim 15, wherein the method furthercomprises: adhering an adhesive patch from the medicament deliverydevice to a user's skin to couple the medicament delivery device to theuser's skin, wherein the housing is coupled to the adhesive patch. 31.The method of claim 15, wherein the method further comprises, after thepin has moved to the second position: moving the plunger relative to themedicament chamber to expel the medicament from the medicament chamber.32. The method of claim 17, wherein the method further comprises: movingthe plunger relative to the medicament chamber over a sustained periodof time for providing a basal delivery of the medicament from themedicament chamber.
 33. The method of claim 17, wherein the plunger ismoved directly or indirectly by a biasing member from the medicamentdelivery device.
 34. The method of claim 15, wherein the medicamentcomprises insulin.